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Oral β-Alanine Supplementation in Patients With COPD (BACOPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
beta-alanine
placebo
control
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • COPD: diagnosis of moderate to very severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
  • Healthy controls: forced expiratory volume at one second/forced vital capacity (FEV1/FVC) > 0.7, matched for age and gender

Exclusion Criteria:

  • The presence of known instable cardiac disease
  • neurological disease and/or musculoskeletal disease that preclude safe participation in an exercise test
  • a history of drugs/alcohol abuse
  • vegetarianism
  • inability to understand the Flemish language.

COPD-specific exclusion criteria:

  • COPD exacerbation and/or hospitalization in the last 6 weeks
  • participation in pulmonary rehabilitation in the previous 12 months.

Sites / Locations

  • Jessa Ziekenhuis (ReGo)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Other

Arm Label

COPD (beta-alanine)

COPD (placebo)

Healthy controls

Arm Description

Outcomes

Primary Outcome Measures

muscle carnosine
by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy
maximal exercise capacity
by means of an incremental maximal cycle test
submaximal exercise capacity
by means of a constant-work rate cycle test

Secondary Outcome Measures

Functional exercise test 1
by means of a 6 minutes walk test
Functional exercise test 2
by means of a 4 meter gait test
Muscle function quadriceps
by means of measuring quadriceps (isometric and isokinetic knee extension-flexion)
Respiratory muscle function
by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure)
Muscle function hand grip
by means of measuring hand grip strength
Muscle characteristics
Structural and metabolic parameters will be measured with dedicated methodology
Blood parameters submaximal exercise test
by means of obtaining venous blood before, during and after the constant-work rate cycle test. Blood parameters will be measured with dedicated methodology.
Blood parameters fasted state
by means of obtaining fasting venous blood. Blood parameters will be measured with dedicated methodology.
Blood parameters maximal exercise test
by means of obtaining venous blood before and after the maximal cycle test. Blood parameters will be measured with dedicated methodology.
Comorbidities
by means of Charlson Morbidity index
Comorbidities: ankle-brachial pressure index
by means of ankle-brachial pressure index
Comorbidities blood pressure
by means of resting systolic and diastolic blood pressure
Comorbidities body composition 1
by means of bio-electrical impedance
Comorbidities body composition 2
by means of whole body dual X-ray absorptiometry
Quality of life: anxiety and depression
by means of the "Hospital Anxiety and Depression Scale"
Quality of life: fatigue
by means of the "Multidimensional Fatigue Inventory"
Quality of life: dyspnea
by means of the " Modified Medical Research Council (MMRC) dyspnea grade"
Quality of life: general
by means of the "Euroqol 5 dimensions (EQ-5D) generic questionnaire"
Quality of life: COPD
by means of the "COPD assessment test"
Physical activity: accelerometer
by means of physical activity monitoring via Actigraph (accelerometer)
Physical activity: questionnaire 1
by means of physical activity monitoring via "Behavioural Regulation in Exercise Questionnaire"
Physical activity: questionnaire 2
by means of physical activity monitoring via "Modified Baecke questionnaire"
Lung function
by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide).
Heart function
by means of resting ECG testing

Full Information

First Posted
May 9, 2016
Last Updated
February 21, 2019
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02770417
Brief Title
Oral β-Alanine Supplementation in Patients With COPD
Acronym
BACOPD
Official Title
Oral β-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD) suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a combination of physical inactivity and muscle oxidative stress. Pilot data (not published) clearly show that patients with COPD have significantly lower carnosine, which is a pH (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in trained and untrained healthy subjects. This study will assess if muscle carnosine can be augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be assessed to compare baseline muscle carnosine levels. The aims of this study are to: Investigate baseline muscle carnosine levels to confirm the pilot data in a larger sample of patients with COPD compared with healthy elderly subjects Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients and whether it has an influence on exercise capacity, lower-limb muscle function and quality of life To investigate baseline and post supplementation structural and metabolic muscle characteristics and markers of oxidative stress and inflammation in COPD patients and it's association with muscle carnosine levels

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD (beta-alanine)
Arm Type
Active Comparator
Arm Title
COPD (placebo)
Arm Type
Placebo Comparator
Arm Title
Healthy controls
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
beta-alanine
Intervention Description
Patients receive beta-alanine
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Patients receive placebo
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
Healthy controls will be assessed to compare baseline muscle carnosine levels
Primary Outcome Measure Information:
Title
muscle carnosine
Description
by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy
Time Frame
change from baseline to 12 weeks
Title
maximal exercise capacity
Description
by means of an incremental maximal cycle test
Time Frame
change from baseline to 12 weeks
Title
submaximal exercise capacity
Description
by means of a constant-work rate cycle test
Time Frame
change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Functional exercise test 1
Description
by means of a 6 minutes walk test
Time Frame
change from baseline to 12 weeks
Title
Functional exercise test 2
Description
by means of a 4 meter gait test
Time Frame
change from baseline to 12 weeks
Title
Muscle function quadriceps
Description
by means of measuring quadriceps (isometric and isokinetic knee extension-flexion)
Time Frame
change from baseline to 12 weeks
Title
Respiratory muscle function
Description
by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure)
Time Frame
change from baseline to 12 weeks
Title
Muscle function hand grip
Description
by means of measuring hand grip strength
Time Frame
change from baseline to 12 weeks
Title
Muscle characteristics
Description
Structural and metabolic parameters will be measured with dedicated methodology
Time Frame
change from baseline to 12 weeks
Title
Blood parameters submaximal exercise test
Description
by means of obtaining venous blood before, during and after the constant-work rate cycle test. Blood parameters will be measured with dedicated methodology.
Time Frame
change from baseline to 12 weeks
Title
Blood parameters fasted state
Description
by means of obtaining fasting venous blood. Blood parameters will be measured with dedicated methodology.
Time Frame
change from baseline to 12 weeks
Title
Blood parameters maximal exercise test
Description
by means of obtaining venous blood before and after the maximal cycle test. Blood parameters will be measured with dedicated methodology.
Time Frame
change from baseline to 12 weeks
Title
Comorbidities
Description
by means of Charlson Morbidity index
Time Frame
change from baseline to 12 weeks
Title
Comorbidities: ankle-brachial pressure index
Description
by means of ankle-brachial pressure index
Time Frame
change from baseline to 12 weeks
Title
Comorbidities blood pressure
Description
by means of resting systolic and diastolic blood pressure
Time Frame
change from baseline to 12 weeks
Title
Comorbidities body composition 1
Description
by means of bio-electrical impedance
Time Frame
change from baseline to 12 weeks
Title
Comorbidities body composition 2
Description
by means of whole body dual X-ray absorptiometry
Time Frame
change from baseline to 12 weeks
Title
Quality of life: anxiety and depression
Description
by means of the "Hospital Anxiety and Depression Scale"
Time Frame
change from baseline to 12 weeks
Title
Quality of life: fatigue
Description
by means of the "Multidimensional Fatigue Inventory"
Time Frame
change from baseline to 12 weeks
Title
Quality of life: dyspnea
Description
by means of the " Modified Medical Research Council (MMRC) dyspnea grade"
Time Frame
change from baseline to 12 weeks
Title
Quality of life: general
Description
by means of the "Euroqol 5 dimensions (EQ-5D) generic questionnaire"
Time Frame
change from baseline to 12 weeks
Title
Quality of life: COPD
Description
by means of the "COPD assessment test"
Time Frame
change from baseline to 12 weeks
Title
Physical activity: accelerometer
Description
by means of physical activity monitoring via Actigraph (accelerometer)
Time Frame
change from baseline to 12 weeks
Title
Physical activity: questionnaire 1
Description
by means of physical activity monitoring via "Behavioural Regulation in Exercise Questionnaire"
Time Frame
change from baseline to 12 weeks
Title
Physical activity: questionnaire 2
Description
by means of physical activity monitoring via "Modified Baecke questionnaire"
Time Frame
change from baseline to 12 weeks
Title
Lung function
Description
by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide).
Time Frame
change from baseline to 12 weeks
Title
Heart function
Description
by means of resting ECG testing
Time Frame
change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: COPD: diagnosis of moderate to very severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines Healthy controls: forced expiratory volume at one second/forced vital capacity (FEV1/FVC) > 0.7, matched for age and gender Exclusion Criteria: The presence of known instable cardiac disease neurological disease and/or musculoskeletal disease that preclude safe participation in an exercise test a history of drugs/alcohol abuse vegetarianism inability to understand the Flemish language. COPD-specific exclusion criteria: COPD exacerbation and/or hospitalization in the last 6 weeks participation in pulmonary rehabilitation in the previous 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martijn Spruit, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jana De Brandt, drs
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis (ReGo)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35977911
Citation
De Brandt J, Derave W, Vandenabeele F, Pomies P, Blancquaert L, Keytsman C, Barusso-Gruninger MS, de Lima FF, Hayot M, Spruit MA, Burtin C. Efficacy of 12 weeks oral beta-alanine supplementation in patients with chronic obstructive pulmonary disease: a double-blind, randomized, placebo-controlled trial. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2361-2372. doi: 10.1002/jcsm.13048. Epub 2022 Aug 17.
Results Reference
derived

Learn more about this trial

Oral β-Alanine Supplementation in Patients With COPD

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